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US FDA delays approval on new drug by Eli Lilly and Daiichi Sankyo news

Posted AtDomain-b.com

US regulators have extended the review period for Eli Lilly and Co and Daiichi Sankyo's new blood-thinning drug Prasugrel, delaying a decision on approval by three months. The Food and Drug Administration (FDA) extended the review period of prasugrel until 26 September as it considers supplemental information, the two companies said in a statement on Monday.

The product, a rival to
Plavix from Sanofi-Aventis and Bristol-Myers Squibb,
is vital to Indianapolis-based Lilly's plan to replace
lost revenue when its top-seller, the antipsychotic
Zyprexa, faces generic competition in 2011. Daiichi
has also expanded its reach in the generics space
with its recent acquisition of India's biggest drugmaker
Ranbaxy.

The companies had submitted
their application to the FDA on 26 December last
year. The application was reviewed on a priority
basis, which shortens the review time to six months
from the typical 10 to 12 months.

Although Daiichi shares
fell on the news, those of its competitors Sanofi-Aventis
and Bristol-Myers Squibb, rose. Daiichi fell 65 yen,
or 2.3 per cent, to 2,770 yen on the Tokyo Stock
Exchange today, the lowest since 13 May Ube Industries
Ltd., a Daiichi Sankyo supplier, fell 2.5 per cent
to 348 yen. In contrast, shares in Sanofi-Aventis
rose 1.7 per cent in early trade.

''We remain confident in
our prasugrel submission package,'' said Jennifer
Stotka, vice president for Global Regulatory Affairs
at Lilly, in a statement. ''We will continue to work
closely with the FDA throughout the review process.''

Dr. Anthony Ware, a Lilly
vice president who leads cardiovascular and acute
care development, said the companies remained confident
in the overall submission package.

The FDA had asked for additional
analyses of the data, Ware said, although he declined
to specify the information that the agency requested. "There's been nothing that's stumped us," he asserted.

The prasugrel application
is the largest in Lilly's history, Ware said. "They certainly have a lot to review in a short period of time," he said.

This optimism was shared
by many industry experts who pointed out that the
companies have neither been requested for additional
data nor asked to attend an advisory panel meeting,
precursors to usual delays or rejections. They consider
the current delay to the large volume of data submitted
by the two companies and the problems of an understaffed
FDA.

The study submitted to
the FDA, funded by Daiichi and Lilly, involved 13,608
patients followed for a little over a year in 30
countries.

In the study, prasugrel
prevented more heart attacks and strokes than Plavix,
an $8.1 billion seller last year. However, more people
taking prasugrel died from bleeding than those taking
Plavix in the trial.

Lilly and Daiichi Sankyo
have started another study called Trilogy, involving
10,000 patients in 35 countries. The study will test
whether prasugrel is better than Plavix in patients
being treated for acute coronary syndrome, a group
of common heart conditions including chest pain and
heart attacks.

If approved, prasugrel
will be marketed as Effient, and is expected to have
a market of $750 million in 2011 and $950 million
by 2015. A three-month delay can potentially cost
$15 million.

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